A Randomized, Double-blind, Active Controlled, 12-week Follow-up, Pilot Study to Evaluate the Safety and Efficacy of Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups
研究概览
简要总结
The objectives of this study is to examine the Safety and Efficacy of black yeast beta-glucan produced from Aureobusidium pulluluns SM-2001 (Polycan), in combination with glucosamine in reducing knee osteoarthritis (OA) associated symptoms. This study is a double-blind, randomized, active-controlled trial conducted with 100 OA patients, aged 35-80 years using a formulated product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of knee osteoarthritis (OA)
- •OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system
- •Agree to participate into the study
排除标准
- •OA ranging from grade 4 by Kellgren and Lawrence system
- •Allergic or contradicted with oral NSAIDs (Meloxicam)
- •Pregnant and breastfeeding women.
研究组 & 干预措施
Glucosamine 1500mg
Glucosamine 1500 mg per day for 12 weeks
干预措施: Glucosamine 1500 mg (Dietary Supplement)
Polycan & Glucosamine 750mg
Polycan 50 mg + Glucosamine 750 mg per day for 12 weeks
干预措施: Polycan 50mg + Glucosamine 750 mg (Dietary Supplement)
Polycan & Glucosamine 1500mg
Polycan 50 mg + Glucosamine 1500 mg per day
干预措施: Polycan 50mg + Glucosamine 1500 mg (Dietary Supplement)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) changes at 12 weeks in the three groups
时间窗: Baseline to Week 12
The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Total WOMAC score ranges from 0 to 96 with higher scores indicate worse pain, stiffness, and functional limitations
次要结局
- Number of dose of rescue medication (Meloxicam 7.5mg) used in the three groups.(Through study completion, an average of 12 weeks)